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Investigating the Inotropic Potential of Apelin

Not Applicable
Completed
Conditions
Heart Failure
Interventions
Drug: Placebo
Registration Number
NCT01179061
Lead Sponsor
University of Edinburgh
Brief Summary

The apelin-APJ system is a recently discover hormone system that has several important actions in the cardiovascular system. Apelin causes the heart pump with more force and also causes blood vessels to relax. Studies to date show that people with reduced pumping function of the heart have lower levels of apelin in the bloodstream compared to people with normal heart function. We have previously given apelin to healthy volunteers and people with reduced pumping function and this increases the heart's contraction. However, this has only been assessed over a short time period, around fifteen minutes, and we now want to know if this effect is seen over a longer period.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
Inclusion Criteria

Healthy volunteers:

>18yrs

Heart failure patients;

  • New York Heart Failure class II-IV
  • Ejection fractional <35% or fractional shortening <20% within previous 6months.
Exclusion Criteria

All subjects,

  • Females of child bearing age not on adequate contraception
  • Lack of informed consent
  • Age <18yrs
  • Current involvement in any other research study
  • Systolic BP >190 or <100
  • Malignant arrhythmias
  • Renal or hepatic failure
  • Haemodynamically significant aortic stenosis
  • Severe or significant co-morbidity
  • Pacemakers

Healthy volunteers

  • Any regular medication
  • Previous history of any cardiovascular disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Apelin infusionApelin6 hour infusion of apelin peptide into circulation
PlaceboPlaceboInfusion of saline into systemic circulation
Primary Outcome Measures
NameTimeMethod
cardiac output6 hours

We will assess, using thoracic bioimpedance cardiography, the change in cardiac output in response to apelin infusion

Secondary Outcome Measures
NameTimeMethod
Urine volume6 hours

All urine will be collected during the studya and we will assess volume and relevant biochemical/humoral factors

Pulmonary artery pressure1 hour

Using echocardiography we will estimate the pulmaonary artery pressure from pulmonary velocity and assess any change during the first hour of study.

Trial Locations

Locations (3)

Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc

🇬🇧

Edinburgh, United Kingdom

Gareth Barnes

🇬🇧

Edinburgh, United Kingdom

University of Edinburgh

🇬🇧

Edinburgh, United Kingdom

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